Quality by Design using Design of Experiments (QbD) 2017

  • 1695.00 Dollar US$
  • Published date: April 24, 2017
    • Singapore, Singapore, Singapore

Course "Quality by Design using Design of Experiments (QbD)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using Design of Experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product Quality System framework defined by requirements in regulatory guidance documents.
Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program.
This systematic understanding should include both identification of significant process parameters and determination of a functional relationship (mathematical model) linking these significant process parameters to the critical Quality Attributes (CQAs). The original guidance document on pharmaceutical development provides general guidance on how these are identified: gaining knowledge about which variation in factors explains variation in product quality characteristics of a drug product. It also provides a means to achieving this knowledge: through the use of formal experimental designs. The use of DOE methodology provides a means to identify those factors that impact product quality characteristics of drug product (or significant process parameters) and determine the functional relationship that links the process parameters to the CQAs.
Although the seminar focuses on the use of DOE for QbD, multiple aspects of QbD are integrated into the course. After learning the relevant applied statistics, participants will understand how statistics can be used to help set specifications and analyze measurement systems, two foundational requirements of QbD. Next participants will learn tools to help them get value out of their designed experiments. Then, participants will learn how to generate and analyze both screening and response surface designs for QbD studies. Lastly, participants will learn how to use this information: best practices on presentation, setting control plans, constructing control charts, and evaluating process capability.


Location: Singapore Date: June 12th & 13th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Mandarin Orchard Singapore
Address: 333 Orchard Road, Singapore 238867 Tel: (65) 6235 7788
Price:

Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until May 10, Early Bird Price: $1,695.00 From May 11 to June 10, Regular Price: $1,895.00

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